Frontiers in drug safety and regulation最新文献

{"title":"The cutaneous mirror: leveraging drug-induced skin phenotypes as early visual risk signals for systemic toxicity, a comprehensive review.","authors":"Hind B Alshalhoob, Lama M Albelowi, Aseel S Alotaibi, Shada Khalid Alanazi, Leen E Alturki, Zahra Saleh Alsindi, Waad Abdulelah Alduraywish, Sarah Anwar Almulla, Ahmed Anwar Almulla, Nouf Abdulaziz Almagushi, Sarah Khalifah Alkhezzi","doi":"10.3389/fdsfr.2026.1825005","DOIUrl":"10.3389/fdsfr.2026.1825005","url":null,"abstract":"<p><p>Drug-induced cutaneous phenotypes can act as early, bedside-visible clinical risk signals of systemic toxicity because the skin externalizes immune dysregulation, epithelial injury, and microvascular disturbance before organ-specific symptoms are obvious. This narrative review synthesizes peer-reviewed human evidence linking drug-related eruptions to systemic harm and actionable clinical decisions. We searched databases through January 2026 with citation chasing and organized findings using a morphology-anchored framework cross mapped to drug classes and mechanisms. High-risk patterns repeatedly signal urgent systemic risk: painful dusky or targetoid lesions with mucosal involvement and blistering/epidermal detachment require immediate culprit withdrawal and admission-level supportive care; widespread eruption with facial edema plus fever, lymphadenopathy, eosinophilia, or atypical lymphocytosis requires drug discontinuation and close monitoring for drug reaction with eosinophilia and systemic symptoms (DRESS). Research priorities include prospective validation of phenotypes as quantitative predictive risk signals, harmonized outcomes, reproducible imaging standards, and bias-aware digital implementation.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1825005"},"PeriodicalIF":0.0,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13294104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148348636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comprehensive pharmacovigilance assessment of pairwise drug-drug interactions and acute pancreatitis in the FDA adverse event reporting system: focus on incretin-based drugs.","authors":"Issei Kazume, Kenji Onda, Sachiko Tanaka, Takashi Yokokawa, Kenichi Suzuki","doi":"10.3389/fdsfr.2026.1827098","DOIUrl":"10.3389/fdsfr.2026.1827098","url":null,"abstract":"<p><strong>Background: </strong>Drug-induced pancreatitis remains a clinically important condition owing to its severity and relevance to pharmacotherapeutic risk management. Incretin-based antidiabetic agents, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-4 (DPP-4) inhibitors, are associated with an increased risk of acute pancreatitis (AP). However, the extent to which concomitant medication modifies AP has not yet been systematically elucidated. We conducted a comprehensive systematic drug-drug interaction (DDI) assessment involving GLP-1 RA and DPP-4 inhibitors using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>Disproportionality analyses were conducted using the FAERS data (JAPIC FAERS) from the fourth quarter of 1997 to the first quarter of 2024. Crude reporting odds ratios (cRORs) were calculated to assess the association between individual drugs and AP. DDI signals for 1:1 concomitant use involving GLP-1 RAs or DPP-4 inhibitors were comprehensively evaluated using the Ω shrinkage measure, with Ω₀₂₅ as the signal detection criterion. Ω₀₂₅ were analyzed for all pooled cases, and temporal trends were assessed across six multi-year periods using a period-stratified analysis.</p><p><strong>Results: </strong>Elevated cRORs for AP were observed for several agents, including GLP-1 RAs, DPP-4 inhibitors, and other antidiabetic medications. Pairwise DDI analyses of GLP-1 RAs or DPP-4 inhibitors with other drugs identified positive interaction signals in 308 drug pairs in pooled analyses. Period-stratified analyses narrowed the findings to 11 drug pairs with consistent signals across ≥3 of 6 periods, including dulaglutide-atorvastatin (four periods). However, no concomitant drug combinations involving GLP-1 RAs or DPP-4 inhibitors were identified as being robustly associated with increased AP reporting.</p><p><strong>Conclusion: </strong>Period-stratified analysis helped mitigate false-positive signals identified in the pooled DDI analyses. Drug pairs exhibiting recurrent weak AP signals warrant continued pharmacovigilance and further evaluation.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1827098"},"PeriodicalIF":0.0,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13291152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148335694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological comparisons for benefit-risk assessment in complex decision-making: applications and insights from a case study.","authors":"Jian-Yu E, Kexin Zhu, Stéphanie Tcherny-Lessenot, Juhaeri Juhaeri","doi":"10.3389/fdsfr.2026.1792441","DOIUrl":"10.3389/fdsfr.2026.1792441","url":null,"abstract":"<p><strong>Background: </strong>Benefit-risk assessment (BRA) can be challenging when integrating benefits, risks, and their relative importance as perceived by physicians or patients. This study aimed to compare eight BRA methodologies though the application and sights from a case study.</p><p><strong>Methods: </strong>Eight BRA methodologies were evaluated using data from European Public Assessment Reports, randomized controlled trials, and published literature on rimonabant, including two descriptive frameworks, two quantitative frameworks, and four metrics and estimation techniques.</p><p><strong>Results: </strong>Descriptive frameworks provided transparent, systematic approaches for structuring BRA and compared alternatives in a series of criteria assessment but lacked quantitative elements and stakeholder weighting. Quantitative frameworks extended these descriptive models by integrating objective data with subjective preferences, enabling the calculation of utility scores or acceptability indexes. Metrics enabled comparison of individual benefit and risk criteria, offering straightforward numerical evaluations.</p><p><strong>Conclusion: </strong>A combination of descriptive and quantitative frameworks allows for a comprehensive BRA, accommodating multiple criteria, stakeholder's preferences, and uncertainties.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1792441"},"PeriodicalIF":0.0,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148335691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the implementation of intermittent versus continuous fetal heart rate monitoring on intrapartum care and early neonatal outcomes using causal mediational modeling.","authors":"Omkar Basnet, Rejina Gurung, Pratiksha Bhattarai, Merlind Maria Hofert, Sunil Mani Pokharel, Prajwal Paudel, Ashish K C","doi":"10.3389/fdsfr.2026.1755487","DOIUrl":"10.3389/fdsfr.2026.1755487","url":null,"abstract":"<p><strong>Introduction: </strong>Intrapartum fetal heart rate (FHR) monitoring can detect fetal compromise and provide indications for early action. However, the effect of implementing intermittent vs. continuous FHR monitoring with Moyo remains unclear. In this study, we compare the effect of implementing intermittent vs. continuous FHR monitoring using Moyo on intrapartum care and neonatal outcomes.</p><p><strong>Methods: </strong>A prospective observational design was used to evaluate two different FHR monitoring methods in seven hospitals in Nepal, with intermittent monitoring as the control group and continuous monitoring as the intervention group. The durations from 1) first Moyo placement to abnormal FHR detection and 2) first abnormal FHR detection to childbirth were compared using generalized linear regression. The causal mediational method assessed the risk of non-crying neonates after birth and intrapartum stillbirth between the groups using the Mantel-Haenszel (M-H) homogeneity method, standardizing the risk for mediators and confounders.</p><p><strong>Results: </strong>A total of 1,091 participants were enrolled during the control period and 8,687 during the intervention period. Compared to the control group, the intervention group was associated with a non-significant reduction in time from first Moyo placement to abnormal FHR monitoring [adj.β = -35·5 min; 95% confidence interval (CI) = -73·2 to 2·22] and a significant reduction in time from first abnormal FHR to delivery (adj.β = -66·5 min; 95% CI = -106·2 to -26·8). The incidence of non-crying neonates was higher in the control group (11·5% vs. 10·0%), with an adjusted risk reduction of 31% (M-H RR = 0·69; 95% CI = 0·55-0·87) in the intervention group. The incidence of intrapartum stillbirth was non-significantly higher in the control group (4.5 vs. 3.0/1,000 births), with an adjusted risk reduced by 35% (M-H RR = 0·65; 95% CI = 0·25-1·70) in the intervention group.</p><p><strong>Conclusion: </strong>Compared with intermittent Moyo, the duration to detect abnormal FHR and the time from abnormal FHR to delivery were significantly reduced, with a 31% reduction in the risk of neonatal resuscitation with continuous Moyo. The implementation of continuous FHR monitoring with portal devices such as Moyo can reduce the time to action following the detection of abnormal fetal heart rates and decrease the burden of infants requiring neonatal resuscitation.</p><p><strong>Clinical trial registration: </strong>clinicaltrials.gov, identifier ISRCTN16741720.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1755487"},"PeriodicalIF":0.0,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287916/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148321506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modafinil and abnormal bleeding in a young lady with narcolepsy: a case report.","authors":"Albatol N Rashed, Ahmed Abdelbasit, Mana Alshahrani","doi":"10.3389/fdsfr.2026.1767644","DOIUrl":"10.3389/fdsfr.2026.1767644","url":null,"abstract":"<p><p>We report the case of a 27-year-old woman with a history of pituitary microadenoma and multiple sclerosis who developed recurrent vaginal bleeding associated with modafinil and methylphenidate use for narcolepsy type 2. The bleeding resolved upon discontinuation of both medications and recurred upon re-exposure. This case highlights a rare but significant adverse effect of stimulant medications and underscores the importance of monitoring in patients with a history of hormonal disorders.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1767644"},"PeriodicalIF":0.0,"publicationDate":"2026-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13283973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148311313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengthening pharmacovigilance and regulatory capacity in Southern Africa (SPaRCS): achievements, experiences and lessons learned from a participatory action learning project.","authors":"Michelle Viljoen, Star Khoza, Mukesh Dheda, Libert Chirinda, Frieda Shigwedha, Anna Shimbulu, SipheSihle Nhlabatsi, Nomsa Shongwe, Albert Figueras, Raffaella Ravinetto, Hazel Bradley","doi":"10.3389/fdsfr.2026.1765077","DOIUrl":"10.3389/fdsfr.2026.1765077","url":null,"abstract":"<p><p>Effective regulatory systems play a critical role in improving access to safe, efficacious and quality medicines and vaccines. However, most regulatory and pharmacovigilance (PV) systems in sub-Saharan Africa (SSA) are still under-resourced and lack recognition of their public health service role, despite encouraging developments in several countries, and positive experiences of harmonization across the continent. The aim of Strengthening pharmacovigilance and regulatory capacities in four Southern African countries (SPaRCS), was to improve pharmacovigilance and clinical trials oversight in Namibia, Eswatini, Zimbabwe and South Africa. The project used a participatory action learning and co-creation approach and built on existing relationships with national regulatory authorities and PV centres in the four countries. Key activities included a mapping of PV and clinical trials oversight in the four partner countries; participatory workshops and learning exchanges in two thematic areas; Strengthening PV systems and Clinical trials oversight, and collaborative development of a training package for community health workers on adverse drug reaction reporting. Intentionally SPaRCS provided opportunities for partners in the four countries to develop relationships amongst those involved in PV and clinical trials oversight in the region. This included sharing of challenges, field experiences and best practices in a sub-national, national and regional setting. Strong commitment of country partners and the flexible learning and co-creation approach facilitated positive achievements. Strengthening PV and clinical trial oversight requires a multi-faceted approach involving the establishment of robust systems, addressing infrastructure and training gaps, integrating PV into public health programs and building formal collaborative platforms at regional level. The regional platform created by SPaRCS provided a starting point, for the establishment of the Centre of Excellence for Pharmacovigilance in Southern Africa (CEPSA) launched at the end of 2024.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1765077"},"PeriodicalIF":0.0,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13270022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148274605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes of post-approval non-interventional safety studies in pregnancy: wide variation demonstrates need for further standardization.","authors":"Stacy Chen, Sarah C MacDonald","doi":"10.3389/fdsfr.2026.1805759","DOIUrl":"10.3389/fdsfr.2026.1805759","url":null,"abstract":"<p><strong>Background: </strong>Upon product approval, sponsors are often required by regulatory authorities (e.g., the United States [US] Food and Drug Administration [FDA] or the European Medicines Agency [EMA]) to conduct post-approval safety studies in pregnant populations. Existing guidance from regulatory authorities provide important recommendations of study outcomes to evaluate in such studies, however harmonized guidance on a priority list of outcomes that all studies must evaluate is currently lacking. This creates inefficiencies in study conduct and limits comparability.</p><p><strong>Objectives: </strong>The article aims to summarize outcomes that are currently being studied across post-approval safety studies in pregnancy and assess the influence of study-related factors on the evaluated outcomes.</p><p><strong>Methods: </strong>A query of post-approval non-interventional pregnancy safety studies registered on the Heads of Medicines Agency [HMA]-EMA Catalogue of Real-world Data [RWD] Studies was conducted, and relevant studies and their protocols were extracted for evaluation. Outcomes were summarized overall and by factors such as data collection method, product type, protocol year, and regulatory agency commitment.</p><p><strong>Results: </strong>Among approximately 3100 studies identified in the catalogue, 30 studies met eligibility criteria for inclusion. The most common outcomes were stillbirth (N = 25 studies), congenital malformations (major or minor) (N = 24), spontaneous abortion (N = 22), small for gestational age or fetal growth restriction (N = 21), and preterm birth or labor (N = 21). Some differences in evaluated outcomes were observed by study characteristics (e.g., regulatory agency commitment, data collection methods, type of active substance, date of protocol). No outcomes were evaluated in all of the studies and none of the studies evaluated all FDA or EMA-recommended outcomes. Sample sizes from completed studies were generally low (median: 110) and few studies had sufficient power to examine commonly evaluated outcomes such as stillbirth and congenital malformations.</p><p><strong>Conclusion: </strong>There was a wide variety of outcomes examined across post-marketing safety studies in pregnancy. Additional harmonized regulatory guidance on required outcomes will improve consistency across studies, allowing for meaningful comparisons and for the more efficient use of existing data.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1805759"},"PeriodicalIF":0.0,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13198923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148020484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Colistin use and outcomes in Kuwait public hospitals.","authors":"Sarah S Alghanem, Wadha A Alfouzan, Moetaza M Soliman, Ebtehal Alroomi, Salma Alajmi, Tarek Mahmoud, Jude Yagan","doi":"10.3389/fdsfr.2026.1808461","DOIUrl":"10.3389/fdsfr.2026.1808461","url":null,"abstract":"<p><strong>Background: </strong>In Kuwait, colistin use has increased owing to an increased incidence of multidrug resistant infections. However, the optimal dosing regimen and its effectiveness and safety are unclear. We aimed to describe colistin use in Kuwait and evaluate the associated clinical outcomes and safety profiles.</p><p><strong>Methods: </strong>This multicentre, retrospective, observational study used data collected from five hospitals. Study outcomes included cure rates, incidence of nephrotoxicity, and mortality. Logistic regression models were used to study the effect of colistin dosing patterns (loading dose, daily maintenance dose, and duration of therapy) on study outcomes. The models were adjusted for age, sex, and hospital unit (ICU/non-ICU), baseline creatinine clearance, being on dialysis, pathogen type, receiving concomitant antibiotics, and site of infection.</p><p><strong>Results: </strong>Of 205 patients treated with colistin, 117 were treated in intensive care units (ICUs) and 88 were treated in other units. Of the 205 patients, 145 (70.7%) achieved clinical cure. The cure rate was lower in ICU patients than in non-ICU patients. Fifty patients experienced nephrotoxicity; 47 died, and 11 experienced neurotoxicity. The incidence of nephrotoxicity did not differ significantly by hospital unit, whereas the case fatality rate was significantly higher and the incidence of neurotoxicity was significantly lower in ICU patients. Administration of a loading dose was not associated with the cure rate, incidence of nephrotoxicity, or case fatality rate. Higher maintenance doses were associated with higher cure rates, (odds ratio [OR], 2.77; 95% confidence interval [CI], 1.04-7.37) and lower fatality rates (OR, 0.29; 95% CI, 0.09-0.95), but more likely to develop nephrotoxicity (OR, 2.60; 95% CI, 1.08-6.23).</p><p><strong>Conclusion: </strong>Administration of high maintenance doses of colistin was associated with higher cure rates but was also associated with a higher incidence of nephrotoxicity.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1808461"},"PeriodicalIF":0.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13194472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148020541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities.","authors":"Carlos G Bernaus, Maria Lilia Bournissen","doi":"10.3389/fdsfr.2026.1821686","DOIUrl":"10.3389/fdsfr.2026.1821686","url":null,"abstract":"<p><strong>Background: </strong>As pharmaceutical development spans multiple continents, marketing authorization holders must simultaneously comply with distinct adverse event reporting frameworks of major health authorities. Although International Council for Harmonisation guidelines provide shared foundations, meaningful differences persist in reporting timelines, case thresholds, and special-situation obligations across jurisdictions.</p><p><strong>Methods: </strong>A narrative review of primary regulatory legislation, guidance documents, peer-reviewed literature, and International Council for Harmonisation guidelines was conducted for five major regulatory authorities: Health Canada, the U.S. Food and Drug Administration, the European Medicines Agency, Japan's Pharmaceuticals and Medical Devices Agency, and China's National Medical Products Administration. These authorities collectively represent the majority of global pharmaceutical market value and clinical trial activity, and each is either an International Council for Harmonisation founding or observer member. Comparative summary tables and decision algorithms were synthesized from authoritative sources across clinical trial, post-marketing, medical device, vaccine, and special-population reporting contexts.</p><p><strong>Results: </strong>All five authorities share International Council for Harmonisation seriousness criteria and require expedited seven-calendar-day reporting for fatal or life-threatening suspected unexpected serious adverse reactions in clinical trials. Key jurisdictional differences include: China's unique 24-h obligation for post-marketing deaths; the European Medicines Agency's device vigilance timelines (10 calendar days for deaths, two calendar days for serious public health threats); the Food and Drug Administration's 30-calendar-day default for manufacturer device reports; the European Medicines Agency's 90-calendar-day obligation for non-serious individual case safety reports from the European Economic Area; and Japan's 30-calendar-day timeline for serious expected domestic adverse drug reactions. The Food and Drug Administration's December 2025 final guidance on sponsor responsibilities further consolidated aggregate analysis obligations, and the proposed transition from the Investigational New Drug Annual Report to the Development Safety Update Report format signals growing emphasis on periodic safety assessment.</p><p><strong>Conclusion: </strong>Effective pharmacovigilance depends on the interplay between expedited individual case reporting and aggregate periodic assessments, including Development Safety Update Reports and Periodic Benefit-Risk Evaluation Reports. A structured decision-tree approach enables marketing authorization holders to manage multi-authority reporting obligations systematically, while ongoing regulatory convergence-exemplified by global adoption of the Development Safety Update Report-reduces submission format burdens.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1821686"},"PeriodicalIF":0.0,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13189745/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148020019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: Pandemic preparedness in vaccine safety and regulation.","authors":"Manal M Younus, Florence van Hunsel","doi":"10.3389/fdsfr.2026.1824880","DOIUrl":"10.3389/fdsfr.2026.1824880","url":null,"abstract":"","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1824880"},"PeriodicalIF":0.0,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13121365/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147795920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}